本文摘譯自MASSDEVICE 2020年4月20日評論

以下為詳文

美國食品和藥物管理局（FDA）向消費者和醫療保健專業人士發出警告，含甲醇的洗手液產品，一旦被皮膚吸收就會有毒，如果人體攝入就會危及生命。甲醇是一種通常用于制造燃料和防凍劑的物質，對洗手液產品來說，它是人體不可接受的活性成分。FDA發現，標簽標示含乙醇（也稱酒精），卻被檢測出甲醇污染呈陽性的洗手液產品，此類情況正在上升。州政府官員還報告了最近來自成人和兒童攝入含甲醇洗手液產品的不良事件，不良事件包括失明、住院和死亡。

FDA繼續警告公眾，不要使用下面網址列出的特定產品（共69家產品），FDA正在與制造商和經銷商進行溝通關于召回這些危險產品的事宜。FDA還將繼續對洗手液產品進行質量檢測，包括通過美國邊境入境的產品檢測，并在網站上保存一份FDA檢測和召回的洗手液清單，清單將隨著危險產品的不斷發現而不斷更新。

網站列表部分截圖

//www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitzers-methanol

FDA專員Stephen M. Hahn說：“所有的美國人都應該養成良好的手衛生習慣，包括在肥皂和水不易獲得的情況下使用含酒精洗手液。令人遺憾的是，有些公司利用冠狀病毒大流行期間洗手液需求量激增的有利形勢，通過銷售含有危險和人體不可接受活性成分的產品，把大伙的生命置于危險之中。消費者和醫療保健提供者都不應再使用含甲醇洗手液?！薄癋DA依然致力于與制造商、藥商、州藥劑委和公眾合作，加強含酒精洗手液的安全供應?！?/span>

今年6月，FDA就Eskbiochem公司生產的含甲醇的產品向消費者發出過警告。從那時起，Eskbiochem公司的幾家經銷商已經發出自愿召回，FDA還勸告其他公司召回其洗手液產品。

FDA竭力勸告消費者保持謹慎，因為其中一些產品仍然會在零售店或網上購買到。

FDA建議消費者立即停止使用這類洗手液，并將瓶子放在危險廢物容器中（若有）處理，或者按照當地廢物管理和回收中心的建議進行處理。請勿將這些產品沖入或倒入下水道中，或與其他液體混合。

人體接觸甲醇會導致惡心、嘔吐、頭痛、視力模糊、永久失明、癲癇發作、昏迷、對神經系統永久性損傷或死亡。雖然使用甲醇洗手液來洗手的人有中毒的危險，但意外攝入這些產品的幼兒和飲用這些產品作為酒精（乙醇）替代品的青少年和成人的風險是最大的。接觸過含甲醇洗手液并出現癥狀的消費者應立即就醫，以逆轉甲醇中毒的毒性作用。

FDA警告含甲醇洗手液比其他洗手液更危及生命的同時，也竭力勸告所有消費者不要飲用任何洗手液產品。這對幼兒尤其是學步兒童尤為重要，學步兒童往往容易被怡人的氣味或色彩鮮艷的瓶子所吸引。美國毒物控制中心在冠狀病毒大流行期間接到關于誤食洗手液的電話不斷增加。重要的措施是，成人應將這些產品放在兒童接觸不到的地方，并監督幼兒的使用情況。

不要在寵物身上使用洗手液，也不要讓寵物吞下洗手液。一旦發現寵物食用了某些有潛在危險的東西，請立即致電獸醫或寵物毒物控制中心。

提醒消費者要經常用肥皂和水洗手至少20秒，尤其是在如廁后、吃飯前、咳嗽、打噴嚏或擤鼻涕后。如果肥皂和水不容易買到，美國疾病控制和預防中心建議消費者使用酒精含量至少為60%的洗手液。

原文：

FDA Takes Action to Warn, Protect Consumers from Dangerous Alcohol-Based Hand Sanitizers Containing Methanol

JULY 2, 2020 BY FDA

As part of continued action to protect the American public, the U.S. Food and Drug Administration is warning consumers and health care professionals about hand sanitizer products containing methanol, or wood alcohol — a substance often used to create fuel and antifreeze that is not an acceptable active ingredient for hand sanitizer products and can be toxic when absorbed through the skin as well as life-threatening when ingested. The agency has seen an increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. State officials have also reported recent adverse events from adults and children ingesting hand sanitizer products contaminated with methanol, including blindness, hospitalizations and death.

The agency continues to warn the public not to use specific products listed here and is communicating with manufacturers and distributors of these dangerous products about recalling them. The FDA also continues to quality-test hand sanitizers, including testing products entering the country through the U.S. border, and maintains a list of FDA-tested and recalled hand sanitizers on the agency’s website, which will be continually updated as dangerous products are discovered. //www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitzers-methanol

“All Americans should practice good hand hygiene, which includes using alcohol-based hand sanitizer if soap and water are not readily available. Unfortunately, there are some companies taking advantage of the increased usage of hand sanitizer during the coronavirus pandemic and putting lives at risk by selling products with dangerous and unacceptable ingredients. Consumers and health care providers should not use methanol-containing hand sanitizers,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA remains committed to working with manufacturers, compounders, state boards of pharmacy and the public to increase the safe supply of alcohol-based hand sanitizers. This includes staying vigilant and continuing to take action when quality issues with hand sanitizers arise.”

In June, the FDA warned consumers about products manufactured by Eskbiochem, which contained methanol. Since then, voluntary recalls have been conducted by several of Eskbiochem’s distributors and the agency is recommending additional companies recall their hand sanitizer products.

The agency urges consumers to be cautious since some of these products may still be found at retail outlets or for purchase online.

The FDA recommends consumers immediately stop using these hand sanitizers and dispose of the bottle in a hazardous waste container, if available, or dispose of as recommended by your local waste management and recycling center. Do not flush or pour these products down the drain or mix with other liquids.

Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although people using these products on their hands are at risk for methanol poisoning, young children who accidentally ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. Consumers who have been exposed to hand sanitizer containing methanol and are experiencing symptoms should seek immediate medical treatment for potential reversal of toxic effects of methanol poisoning.

While methanol-containing hand sanitizers are more life-threatening than others, the FDA urges all consumers not to drink any hand sanitizer product. This is particularly important for young children, especially toddlers, who may be attracted by the pleasant smell or brightly colored bottles. During the pandemic, poison control centers have had an increase in calls about accidental ingestion of hand sanitizer, and it is important that adults keep these products out of reach of children and monitor young children’s use.

Do not use hand sanitizer on pets or allow pets to swallow hand sanitizer. If you believe your pet has eaten something potentially dangerous, call a veterinarian or a pet poison control center immediately.

Consumers are reminded to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; and after coughing, sneezing or blowing one’s nose. If soap and water are not readily available, the U.S. Centers for Disease Control and Prevention recommends consumers use an alcohol-based hand sanitizer that contains at least 60 percent ethanol.

The FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program (please provide the agency with as much information as possible to identify the product):

Complete and submit the report online, or

Download and complete the form, then submit it via fax at 1-800-FDA-0178.

Consumers, manufacturers or distributors who have questions for the FDA regarding hand sanitizers should email COVID-19-Hand-Sanitizers@fda.hhs.gov.